Trial Outcomes & Findings for A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants (NCT NCT02271425)

NCT ID: NCT02271425

Last Updated: 2019-03-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 8 participants
• Primary outcome timeframe: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.25, 4.5, 5, 5.5, 6, 6.5, 8, 10, 12, Day 2; 24, 36 Day 3; 48 Day 4; 72 Day 5; 96 Day 6; 120 Day 7; 144 and Day 8; 168 hours post-dose
• Results posted on: 2019-03-01

Participant Flow

Participant milestones

Measure	Evacetrapib Tablet + Evacetrapib Intravenous Single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)\[¹³C₈\] evacetrapib administered over a 4 hour infusion.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants

Baseline characteristics by cohort

Measure	Evacetrapib Tablet + Evacetrapib Intravenous n=8 Participants Single oral dose of 130 mg evacetrapib tablet + a single IV dose of 175 µg \[¹³C₈\] evacetrapib administered over a 4 hour infusion.
Age, Continuous	42.9 years STANDARD_DEVIATION 14.1 • n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United Kingdom	8 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.25, 4.5, 5, 5.5, 6, 6.5, 8, 10, 12, Day 2; 24, 36 Day 3; 48 Day 4; 72 Day 5; 96 Day 6; 120 Day 7; 144 and Day 8; 168 hours post-dose

Population: All participants who received at least one dose of study drug and had evaluable PK data

Outcome measures

Measure	Evacetrapib: Tablet n=8 Participants A single oral dose of 130 mg evacetrapib tablet	Evacetrapib: Intravenous n=8 Participants A single IV dose of 175 μg \[¹³C₈\] evacetrapib administered over a 4 hour infusion.
Pharmacokinetics (PK): Dose Normalized Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib	111 nanogramxhour/milliliter/mg (ngxh/ml/mg) Geometric Coefficient of Variation 21	248 nanogramxhour/milliliter/mg (ngxh/ml/mg) Geometric Coefficient of Variation 16

Adverse Events

Evacetrapib Tablet + Evacetrapib Intravenous

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Evacetrapib Tablet + Evacetrapib Intravenous n=8 participants at risk Single oral dose of 130 mg evacetrapib tablet + a single IV dose of 175 µg \[¹³C₈\] evacetrapib administered over a 4 hour infusion.
General disorders Catheter site pain	12.5% 1/8 • Number of events 1 The adverse events were collected from participants who received simultaneous administration of a single oral dose and a 4-hour intravenous (IV) infusion.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Number of events 2 The adverse events were collected from participants who received simultaneous administration of a single oral dose and a 4-hour intravenous (IV) infusion.
Nervous system disorders Headache	25.0% 2/8 • Number of events 2 The adverse events were collected from participants who received simultaneous administration of a single oral dose and a 4-hour intravenous (IV) infusion.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60